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Tag: "documented information" - Expert Advice Community

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  • Documentation Requirements, Corrective Action and Nonconforming Product

    Revision D. We had an auditor tell us that "the standard requires us to document" items like counterfeit parts within the Nonconforming product process specifically (even though we already have it in another process) and human factors documented in the Corrective Actions process specifically. Both of which actually don't state that they need to be documented in the process, but instead need to be determined or ensured coverage (which would be seen in the completion of the process in its own inherently). I don't believe the auditor is accurate in his statement based on how the standard is written. Wanting to get another person's perspective on this.